【日本的第一三共製藥疫苗第三期臨床沒有使用免疫橋接】,不要又被騙了
對抗政府的認知作戰真辛苦,到處都會冒出新的假新聞來,請大家不要被騙了!目前全世界只有台灣在二期臨床還沒結束,沒有進行三期,在不公開專家會議不敢錄影的狀況下,只以免疫橋接來授予疫苗緊急使用權!
先請看這篇投書:『日本疫苗「非」採用免疫橋接』
https://www.storm.mg/article/3823044 【「非劣性試驗」和「免疫橋接」有何不同?主要的差別就在於「非劣性試驗」得到的數據,是臨床施打疫苗後染病與無染病的人數,故能與對照疫苗直接比較臨床療效或效力(effectiveness/efficacy),這是真正的臨床第三期研究,是一種FDA(美國聯邦藥物食品監督管理局)早就認可的方式;然而「免疫橋接」只是施打後在實驗室比較中和抗體量,是間接的證據,無法證明兩者保護力是否相當,因此至今不被FDA接受用於申請EUA(緊急使用授權)。】
然後查證日經亞洲的原文:Japan nears homegrown vaccine with Daiichi Sankyo Phase 3 trials
https://asia.nikkei.com/Spotlight/Coronavirus/Japan-nears-homegrown-vaccine-with-Daiichi-Sankyo-Phase-3-trials
"So Daiichi Sankyo's next trial is expected to test non-inferiority, meaning that the goal is to show the company's new treatment matches or outperforms those made by Pfizer and Moderna -- also mRNA shots -- in terms of efficacy. Details of the study are being ironed out with the health ministry."
日經的日文報導中寫的也是非劣性實驗
https://www.nikkei.com/article/DGXZQOUC12116012072021000000/
"治験の詳細は厚生労働省と協議中だが、すでに国内で普及するファイザーやモデルナ製と比べて有効性に遜色がないかを明らかにする「非劣性試験」を採用する見通し。従来の医薬品の治験とは異なり、偽の薬を投与する必要がない。国内外の感染拡大に収束のメドが立たないなか、既存ワクチンがありながら偽薬をうつという倫理的な問題が解消され、治験参加者を集めやすいなどのメリットがある。
生産は子会社の第一三共バイオテック(埼玉県北本市)が担う。22年3月までにワクチンを生産する体制を整える。生産能力は治験の結果などから判断する。"
同時也有2部Youtube影片,追蹤數超過12萬的網紅朱學恒的阿宅萬事通事務所,也在其Youtube影片中提到,Twitch傳送門: https://www.twitch.tv/otakuarmy2 聽黨指揮,永遠跟黨走,黨在我心中,世界第一免疫橋接疫苗是我大台灣第一,只要聽黨話,病毒也會無力化~~~~我編這個超棒的是不是可以加入民進黨? 根據聯合報的報導:【衛福部食藥署前天通過高端新冠肺炎疫苗緊急授權...
trial test meaning 在 朱學恒的阿宅萬事通事務所 Facebook 八卦
YT傳送門:
https://youtu.be/FL9hqvgcXP4
Twitch傳送門: https://www.twitch.tv/otakuarmy2
聽黨指揮,永遠跟黨走,黨在我心中,世界第一免疫橋接疫苗是我大台灣第一,只要聽黨話,病毒也會無力化~~~~我編這個超棒的是不是可以加入民進黨?
根據聯合報的報導:【衛福部食藥署前天通過高端新冠肺炎疫苗緊急授權(EUA)申請,准許專案製造,在野黨批評是照劇本演出。行政院長蘇貞昌今天表示,學者專家高比例來通過,政府也都尊重專業,也請食藥署依據專業程序來走,「請國人同胞相信政府,一定以安全有效為唯一原則」】
高端疫苗通過緊急授權(EUA)這件事不說還好,一說我就有氣。美國評斷疫苗通過與否的過程如何?根據nownews的報導:【美國食品藥品監督管理局(FDA)早前在2020年11月訂出緊急使用授權的相關標準,疫苗解盲的審查過程採取線上直播會議,諮詢委員的投票結果也以公開具名的形式進行。】,【FDA強調,這些諮詢委員經過仔細篩選,排除掉任何存在利益衝突的人士,以便公眾、科學界能夠更清楚的了解新冠疫苗。根據FDA官網,目前諮詢委員會有18個成員,1個席次從缺,主席為德州休斯頓大學醫學院博士、傳染病學教授沙利(Hana El Sahly),成員包括臨床研究、兒科、免疫與呼吸疾病、病理學等各領域的醫學專家,以及行業代表「Head of Medical Affairs」副總裁、FDA生物製品評估研究中心負責人、聯邦政府指定科學顧問。】好啦,鏡頭回到台灣,人家是雞腿,我們是甚麼小?
我們有二十一個藏頭不露臉連名字筆畫生辰八字都不知道的專家,在會議內容完全沒有透露,不要說直播,連錄音綠影都沒有的狀況下,這麼重要攸關全國人民生死的會議竟然就這麼通過了,民眾最多只知道票數而已,媽的這些委員以為自己是蝙蝠俠嗎?藏頭藏尾連紀錄都沒有是有甚麼不可見人的地方?你是專家就要勇敢拿出自己的專業跟社會抗衡啊?!
現在在民進黨擔任黨職月領九萬的林飛帆2014年曾經說,【台灣現行的代議政治、民主制度,已經在行政權專擅獨大的情況底下,被摧毀殆盡;我們現行的代議民主,已經被黨紀、被個人的意志鯨吞蠶食,已經無法回應民意了。】幹,機歪,過了七年之後除了林飛帆薪水增加之外,他媽的台灣狀況越來越糟,我們連土製疫苗怎麼過的都沒有權利知道,這是不是很荒謬?
根據聯合報的報導:【食藥署通過高端疫苗「緊急使用授權」(EUA),並提出「在高端疫苗組AZ疫苗組原型株活病毒」中和抗體幾何平均效價比值的95%信賴區間下限為3.4倍,大於標準要求0.67倍。」,數據漂亮,但中研院院士陳培哲卻說,「這是沒有用的數字,不具有任何參考價值,他連看都不想看。」,放眼全球,也只有台灣這樣做,可說是另類的台灣第一。】
然後最近又有媒體如獲至寶的說日本第一三共使用免疫橋接啦,我國食藥署真是未卜先知啦~~~等等,我上網查了一下不是這樣啊!人家都寫了non-inferiority就是沒說到免疫橋接IMMUNO BRIDGING啊!科學是有甚麼說甚麼,這裡面研究法就是沒提到啊!
日經的日文報導中寫的是非劣性實驗
https://www.nikkei.com/article/DGXZQOUC12116012072021000000/
"治験の詳細は厚生労働省と協議中だが、すでに国内で普及するファイザーやモデルナ製と比べて有効性に遜色がないかを明らかにする「非劣性試験」を採用する見通し。従来の医薬品の治験とは異なり、偽の薬を投与する必要がない。国内外の感染拡大に収束のメドが立たないなか、既存ワクチンがありながら偽薬をうつという倫理的な問題が解消され、治験参加者を集めやすいなどのメリットがある。
日經亞洲的英文原文:Japan nears homegrown vaccine with Daiichi Sankyo Phase 3 trials
https://asia.nikkei.com/Spotlight/Coronavirus/Japan-nears-homegrown-vaccine-with-Daiichi-Sankyo-Phase-3-trials
"So Daiichi Sankyo's next trial is expected to test non-inferiority, meaning that the goal is to show the company's new treatment matches or outperforms those made by Pfizer and Moderna -- also mRNA shots -- in terms of efficacy. Details of the study are being ironed out with the health ministry."
我差點忘記阿亮堅持要談的國防安全院的ptt都是中共同路人的報告了!根據聯合報的報導:【在政府採購COVID-19疫苗策略備受質疑之際,財團法人國防安全研究院發布最新研究報告宣稱,在PTT八卦版發現「奇怪的趨勢」,指稱搧動情緒的敘事模式正逐漸占據跟疫情有關的討論,使得八卦版作為疫情交流平台的功能逐漸癱瘓,而研究使用文字雲等方法,辨識出有267個帳號有協同性質操作相關議題,而且帳號都有快速周旋於不同國家的特性。研究後記認為,在群眾找情緒出口之際,可能以輿論的形式試圖為中國大陸科興與國藥在台打開窗口,對台灣政府製造防疫施政的壓力。】
但是根據風傳媒的報導:【國防研究院日前發布報告,指出網路論壇批踢踢實業坊(PTT)八卦板已被煽動情緒占據,並列出其中47個活躍帳號。不過,國民黨台北市議員徐巧芯徹查這47個帳號,發現這些帳號反國民黨、反中國、支持民進黨的比例高達74%。】現在要打倒反黨反革命只需要意見不同就夠了嗎?連罪證都不用喔,郭正亮有想過國防部底下的智庫可以做這種研究嗎?
另外,昨天最熱鬧的新聞竟然跟郭正亮有關,怎麼搞得! 根據蘋果新聞網的報導:【羽球球后戴資穎揭露東京奧運台灣代表團選手搭經濟艙,在國內引發波瀾,而亞洲羽球強國印尼,也注意到了此事,印尼《Tribun news》今天報導,戴資穎出征東奧搭乘經濟艙,讓戴資穎的父親痛批台灣政府。《Tribun news》這篇報導中,主要是在描述戴資穎父親的說法,指戴爸因為女兒搭經濟艙出征東奧感到不滿,認為應該獲得更好的對待,如果政府無法安排,應該提前通知,讓選手自己安排行程,而不是等選手搭機才知道情況。整篇報導並未提到台灣政府後續作法等等。】
因為郭正亮以前就是體委會副主委,也是羽球協會理事長啊!如果今天他不是被流放,今天大家要罵的就是郭正亮了啦!逃過一劫的郭正亮一定很高興啊哈哈哈,不然我們就問他內幕到底是甚麼啦!
今天沒有贊助的晚餐是晶華酒店的高檔散壽司~~~價格:2960元~~~~
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trial test meaning 在 江魔的魔界(Kong Keen Yung 江健勇) Facebook 八卦
這是前些日子爆出已經被加拿大法院接理對藏傳佛教噶舉派法王的訟訴。(加拿大法院鏈接在此:https://www.bccourts.ca/jdb-txt/sc/21/09/2021BCSC0939cor1.htm?fbclid=IwAR2FLZlzmUIGTBaTuKPVchEqqngcE3Qy6G_C0TWNWVKa2ksbIYkVJVMQ8f8)
這位法王的桃色事件,我是幾年前才聽到。但,藏傳佛教的高層有這些性醜聞,我已經聽了幾十年。我以前的一位前女友也被一些堪布藉故上她的家摟抱過,也有一些活佛跟她表白。(這不只是她,其他地方我也聽過不少)
這是一個藏傳佛教裡面系統式的問題。
很多時候發生這種事情,信徒和教主往往都是說女方得不到寵而報仇,或者說她們也精神病,或者說她們撒謊。
我不排除有這種可能性,但,多過一位,甚至多位出來指證的時候,我是傾向於相信『沒有那麼巧這麼多有精神病的女人要撒謊來報仇』。
大寶法王的桃色事件,最先吹哨的是一位台灣的在家信徒,第二位是香港的女出家人,現在加拿大又多一位公開舉報上法庭。
對大寶法王信徒來說,這一次的比較麻煩,因為是有孩子的。(關於有孩子的,我早在法王的桃色事件曝光時,就有聽聞)
如果法庭勒令要驗證DNA,這對法王和他的信徒來說,會很尷尬和矛盾,因為做或不做,都死。
你若問我,我覺得『人數是有力量的』,同時我也覺得之後有更多的人站出來,是不出奇的。
我也藉此呼籲各方佛教徒,如果你們真的愛佛教,先別說批判,但如鴕鳥般不討論這些爭議,你是間接害了佛教。
(下面是我從加拿大法院鏈接拷貝下來的內容,當中有很多細節。)
Table of Contents
INTRODUCTION
BACKGROUND
ANALYSIS
A. The Spousal Support Claim in this Case
B. The Test to Amend Pleadings
C. Pleadings in Family Law Cases
D. The Legal Concept of a Marriage-Like Relationship
E. Is There a Reasonable Claim of a Marriage-Like Relationship?
F. Delay / Prejudice
CONCLUSION
INTRODUCTION
[1] The claimant applies to amend her notice of family claim to seek spousal support. At issue is whether the claimant’s allegations give rise to a reasonable claim she lived with the respondent in a marriage-like relationship, so as to give rise to a potential entitlement to spousal support under the Family Law Act, S.B.C. 2011, c. 25 (“FLA”).
[2] The facts alleged by the claimant do not fit within a traditional concept of marriage. The claimant does not allege that she and the respondent ever lived together. Indeed, she has only met the respondent in person four times: twice very briefly in a public setting; a third time in private, when she alleges the respondent sexually assaulted her; and a fourth and final occasion, when she informed the respondent she was pregnant with his child.
[3] The claimant’s case is that what began as a non-consensual sexual encounter evolved into a loving and affectionate relationship. That relationship occurred almost entirely over private text messages. The parties rarely spoke on the telephone, and never saw one another during the relationship, even over video. The claimant says they could not be together because the respondent is forbidden by his station and religious beliefs from intimate relationships or marriage. Nonetheless, she alleges, they formed a marriage-like relationship that lasted from January 2018 to January 2019.
[4] The respondent denies any romantic relationship with the claimant. While he acknowledges providing emotional and financial support to the claimant, he says it was for the benefit of the child the claimant told him was his daughter.
[5] The claimant’s proposed amendment raises a novel question: can a secret relationship that began on-line and never moved into the physical world be like a marriage? In my view, that question should be answered by a trial judge after hearing all of the evidence. The alleged facts give rise to a reasonable claim the claimant lived with the respondent in a marriage-like relationship. Accordingly, I grant the claimant leave to amend her notice of family claim.
BACKGROUND
[6] It should be emphasized that this is an application to amend pleadings only. The allegations by the claimant are presumed to be true for the purposes of this application. Those allegations have not been tested in a court of law.
[7] The respondent, Ogyen Trinley Dorje, is a high lama of the Karma Kagyu School of Tibetan Buddhism. He has been recognized and enthroned as His Holiness, the 17th Gyalwang Karmapa. Without meaning any disrespect, I will refer to him as Mr. Dorje in these reasons for judgment.
[8] Mr. Dorje leads a monastic and nomadic lifestyle. His true home is Tibet, but he currently resides in India. He receives followers from around the world at the Gyuto Monetary in India. He also travels the world teaching Tibetan Buddhist Dharma and hosting pujas, ceremonies at which Buddhists express their gratitude and devotion to the Buddha.
[9] The claimant, Vikki Hui Xin Han, is a former nun of Tibetan Buddhism. Ms. Han first encountered Mr. Dorje briefly at a large puja in 2014. The experience of the puja convinced Ms. Han she wanted to become a Buddhist nun. She met briefly with Mr. Dorje, in accordance with Kagyu traditions, to obtain his approval to become a nun.
[10] In October 2016, Ms. Han began a three-year, three-month meditation retreat at a monastery in New York State. Her objective was to learn the practices and teachings of the Kagyu Lineage. Mr. Dorje was present at the retreat twice during the time Ms. Han was at the monastery.
[11] Ms. Han alleges that on October 14, 2017, Mr. Dorje sexually assaulted her in her room at the monastery. She alleges that she became pregnant from the assault.
[12] After she learned that she was pregnant, Ms. Han requested a private audience with Mr. Dorje. In November 2017, in the presence of his bodyguards, Ms. Han informed Mr. Dorje she was pregnant with his child. Mr. Dorje initially denied responsibility; however, he provided Ms. Han with his email address and a cellphone number, and, according to Ms. Han, said he would “prepare some money” for her.
[13] Ms. Han abandoned her plan to become a nun, left the retreat and returned to Canada. She never saw Mr. Dorje again.
[14] After Ms. Han returned to Canada, she and Mr. Dorje began a regular communication over an instant messaging app called Line. They also exchanged emails and occasionally spoke on the telephone.
[15] The parties appear to have expressed care and affection for one another in these communications. I say “appear to” because it is difficult to fully understand the meaning and intentions of another person from brief text messages, especially those originally written in a different language. The parties wrote in a private shorthand, sharing jokes, emojis, cartoon portraits and “hugs” or “kisses”. Ms. Han was the more expressive of the two, writing more frequently and in longer messages. Mr. Dorje generally participated in response to questions or prompting from Ms. Han, sometimes in single word messages.
[16] Ms. Han deposes that she believed Mr. Dorje was in love with her and that, by January 2018, she and Mr. Dorje were living in a “conjugal relationship”.
[17] During their communications, Ms. Han expressed concern that her child would be “illegitimate”. She appears to have asked Mr. Dorje to marry her, and he appears to have responded that he was “not ready”.
[18] Throughout 2018, Mr. Dorje transferred funds in various denominations to Ms. Han through various third parties. Ms. Han deposes that these funds were:
a) $50,000 CDN to deliver the child and for postpartum care she was to receive at a facility in Seattle;
b) $300,000 CDN for the first year of the child’s life;
c) $20,000 USD for a wedding ring, because Ms. Han wrote “Even if we cannot get married, you must buy me a wedding ring”;
d) $400,000 USD to purchase a home for the mother and child.
[19] On June 19, 2018, Ms. Han gave birth to a daughter in Richmond, B.C.
[20] On September 17, 2018, Mr. Dorje wrote, ”Taking care of her and you are my duty for life”.
[21] Ms. Han’s expectation was that the parties would live together in the future. She says they planned to live together. Those plans evolved over time. Initially they involved purchasing a property in Toronto, so that Mr. Dorje could visit when he was in New York. They also discussed purchasing property in Calgary or renting a home in Vancouver for that purpose. Ms. Han eventually purchased a condominium in Richmond using funds provided by Mr. Dorje.
[22] Ms. Han deposes that the parties made plans for Mr. Dorje to visit her and meet the child in Richmond. In October 2018, however, Mr. Dorje wrote that he needed to “disappear” to Europe. He wrote:
I will definitely find a way to meet her
And you
Remember to take care of yourself if something happens
[23] The final plan the parties discussed, according to Ms. Han, was that Mr. Dorje would sponsor Ms. Han and the child to immigrate to the United States and live at the Kagyu retreat centre in New York State.
[24] In January 2019, Ms. Han lost contact with Mr. Dorje.
[25] Ms. Han commenced this family law case on July 17, 2019, seeking child support, a declaration of parentage and a parentage test. She did not seek spousal support.
[26] Ms. Han first proposed a claim for spousal support in October 2020 after a change in her counsel. Following an exchange of correspondence concerning an application for leave to amend the notice of family claim, Ms. Han’s counsel wrote that Ms. Han would not be advancing a spousal support claim. On March 16, 2020, counsel reversed course, and advised that Ms. Han had instructed him to proceed with the application.
[27] When this application came on before me, the trial was set to commence on June 7, 2021. The parties were still in the process of discoveries and obtaining translations for hundreds of pages of documents in Chinese characters.
[28] At a trial management conference on May 6, 2021, noting the parties were not ready to proceed, Madam Justice Walkem adjourned the trial to April 11, 2022.
ANALYSIS
A. The Spousal Support Claim in this Case
[29] To claim spousal support in this case, Ms. Han must plead that she lived with Mr. Dorje in a marriage-like relationship. This is because only “spouses” are entitled to spousal support, and s. 3 of the Family Law Act defines a spouse as a person who is married or has lived with another person in a marriage-like relationship:
3 (1) A person is a spouse for the purposes of this Act if the person
(a) is married to another person, or
(b) has lived with another person in a marriage-like relationship, and
(i) has done so for a continuous period of at least 2 years, or
(ii) except in Parts 5 [Property Division] and 6 [Pension Division], has a child with the other person.
[30] Because she alleges she has a child with Mr. Dorje, Ms. Han need not allege that the relationship endured for a continuous period of two years to claim spousal support; but she must allege that she lived in a marriage-like relationship with him at some point in time. Accordingly, she must amend the notice of family claim.
B. The Test to Amend Pleadings
[31] Given that the notice of trial has been served, Ms. Han requires leave of the court to amend the notice of family claim: Supreme Court Family Rule 8-1(1)(b)(i).
[32] A person seeking to amend a notice of family claim must show that there is a reasonable cause of action. This is a low threshold. What the applicant needs to establish is that, if the facts pleaded are proven at trial, they would support a reasonable claim. The applicant’s allegations of fact are assumed to be true for the purposes of this analysis. Cantelon v. Wall, 2015 BCSC 813, at para. 7-8.
[33] The applicant’s delay, the reasons for the delay, and the prejudice to the responding party are also relevant factors. The ultimate consideration is whether it would be just and convenient to allow the amendment. Cantelon, at para. 6, citing Teal Cedar Products Ltd. v. Dale Intermediaries Ltd. et al (1986), 19 B.C.L.R. (3d) 282.
C. Pleadings in Family Law Cases
[34] Supreme Court Family Rules 3-1(1) and 4-1(1) require that a claim to spousal support be pleaded in a notice of family claim in Form F3. Section 2 of Form F3, “Spousal relationship history”, requires a spousal support claimant to check the boxes that apply to them, according to whether they are or have been married or are or have been in a marriage-like relationship. Where a claimant alleges a marriage-like relationship, Form F3 requires that they provide the date on which they began to live together with the respondent in a marriage-like relationship and, where applicable, the date on which they separated. Form F3 does not require a statement of the factual basis for the claim of spousal support.
[35] In this case, Ms. Han seeks to amend the notice of family claim to allege that she and Mr. Dorje began to live in a marriage-like relationship in or around January 2018, and separated in or around January 2019.
[36] An allegation that a person lived with a claimant in a marriage-like relationship is a conclusion of law, not an allegation of fact. Unlike the rules governing pleadings in civil actions, however, the Supreme Court Family Rules do not expressly require family law claimants to plead the material facts in support of conclusions of law.
[37] In other words, there is no express requirement in the Supreme Court Family Rules that Ms. Han plead the facts on which she relies for the allegation she and Mr. Dorje lived in a marriage-like relationship.
[38] Rule 4-6 authorizes a party to demand particulars, and then apply to the court for an order for further and better particulars, of a matter stated in a pleading. However, unless and until she is granted leave and files the proposed amended notice of family claim, Ms. Han’s allegation of a marriage-like relationship is not a matter stated in a pleading.
[39] Ms. Han filed an affidavit in support of her application to amend the notice of family claim. Normally, evidence would not be required or admissible on an application to amend a pleading. However, in the unusual circumstances of this case, the parties agreed I may look to Ms. Han’s affidavit and exhibits for the facts she pleads in support of the allegation of a marriage-like relationship.
[40] Because this is an application to amend - and Ms. Han’s allegations of fact are presumed to be true - I have not considered Mr. Dorje’s responding affidavit.
[41] Relying on affidavit evidence for an application to amend pleadings is less than ideal. It tends to merge and confuse the material facts with the evidence that would be relied on to prove those facts. In a number of places in her affidavit, for example, Ms. Han describes her feelings, impressions and understandings. A person’s hopes and intentions are not normally material facts unless they are mutual or reasonably held. The facts on which Ms. Han alleges she and Mr. Dorje formed a marriage-like relationship are more important for the present purposes than her belief they entered into a conjugal union.
[42] Somewhat unusually, in this case, almost all of the parties’ relevant communications were in writing. This makes it somewhat easier to separate the facts from the evidence; however, as stated above, it is difficult to understand the intentions and actions of a person from brief text messages.
[43] In my view, it would be a good practice for applicants who seek to amend their pleadings in family law cases to provide opposing counsel and the court with a schedule of the material facts on which they rely for the proposed amendment.
D. The Legal Concept of a Marriage-Like Relationship
[44] As Mr. Justice Myers observed in Mother 1 v. Solus Trust Company, 2019 BCSC 200, the concept of a marriage-like relationship is elastic and difficult to define. This elasticity is illustrated by the following passage from Yakiwchuk v. Oaks, 2003 SKQB 124, quoted by Myers J. at para. 133 of Mother 1:
[10] Spousal relationships are many and varied. Individuals in spousal relationships, whether they are married or not, structure their relationships differently. In some relationships there is a complete blending of finances and property - in others, spouses keep their property and finances totally separate and in still others one spouse may totally control those aspects of the relationship with the other spouse having little or no knowledge or input. For some couples, sexual relations are very important - for others, that aspect may take a back seat to companionship. Some spouses do not share the same bed. There may be a variety of reasons for this such as health or personal choice. Some people are affectionate and demonstrative. They show their feelings for their “spouse” by holding hands, touching and kissing in public. Other individuals are not demonstrative and do not engage in public displays of affection. Some “spouses” do everything together - others do nothing together. Some “spouses” vacation together and some spend their holidays apart. Some “spouses” have children - others do not. It is this variation in the way human beings structure their relationships that make the determination of when a “spousal relationship” exists difficult to determine. With married couples, the relationship is easy to establish. The marriage ceremony is a public declaration of their commitment and intent. Relationships outside marriage are much more difficult to ascertain. Rarely is there any type of “public” declaration of intent. Often people begin cohabiting with little forethought or planning. Their motivation is often nothing more than wanting to “be together”. Some individuals have chosen to enter relationships outside marriage because they did not want the legal obligations imposed by that status. Some individuals have simply given no thought as to how their relationship would operate. Often the date when the cohabitation actually began is blurred because people “ease into” situations, spending more and more time together. Agreements between people verifying when their relationship began and how it will operate often do not exist.
[45] In Mother 1, Mr. Justice Myers referred to a list of 22 factors grouped into seven categories, from Maldowich v. Penttinen, (1980), 17 R.F.L. (2d) 376 (Ont. Dist. Ct.), that have frequently been cited in this and other courts for the purpose of determining whether a relationship was marriage-like, at para. 134 of Mother 1:
1. Shelter:
(a) Did the parties live under the same roof?
(b) What were the sleeping arrangements?
(c) Did anyone else occupy or share the available accommodation?
2. Sexual and Personal Behaviour:
(a) Did the parties have sexual relations? If not, why not?
(b) Did they maintain an attitude of fidelity to each other?
(c) What were their feelings toward each other?
(d) Did they communicate on a personal level?
(e) Did they eat their meals together?
(f) What, if anything, did they do to assist each other with problems or during illness?
(g) Did they buy gifts for each other on special occasions?
3. Services:
What was the conduct and habit of the parties in relation to:
(a) preparation of meals;
(b) washing and mending clothes;
(c) shopping;
(d) household maintenance; and
(e) any other domestic services?
4. Social:
(a) Did they participate together or separately in neighbourhood and community activities?
(b) What was the relationship and conduct of each of them toward members of their respective families and how did such families behave towards the parties?
5. Societal:
What was the attitude and conduct of the community toward each of them and as a couple?
6. Support (economic):
(a) What were the financial arrangements between the parties regarding the provision of or contribution toward the necessaries of life (food, clothing, shelter, recreation, etc.)?
(b) What were the arrangements concerning the acquisition and ownership of property?
(c) Was there any special financial arrangement between them which both agreed would be determinant of their overall relationship?
7. Children:
What was the attitude and conduct of the parties concerning children?
[46] In Austin v. Goerz, 2007 BCCA 586, the Court of Appeal cautioned against a “checklist approach”; rather, a court should "holistically" examine all the relevant factors. Cases like Molodowich provide helpful indicators of the sorts of behaviour that society associates with a marital relationship, the Court of Appeal said; however, “the presence or absence of any particular factor cannot be determinative of whether a relationship is marriage-like” (para. 58).
[47] In Weber v. Leclerc, 2015 BCCA 492, the Court of Appeal again affirmed that there is no checklist of characteristics that will be found in all marriages and then concluded with respect to evidence of intentions:
[23] The parties’ intentions – particularly the expectation that the relationship will be of lengthy, indeterminate duration – may be of importance in determining whether a relationship is “marriage-like”. While the court will consider the evidence expressly describing the parties’ intentions during the relationship, it will also test that evidence by considering whether the objective evidence is consonant with those intentions.
[24] The question of whether a relationship is “marriage-like” will also typically depend on more than just their intentions. Objective evidence of the parties’ lifestyle and interactions will also provide direct guidance on the question of whether the relationship was “marriage-like”.
[48] Significantly for this case, the courts have looked to mutual intent in order to find a marriage-like relationship. See, for example, L.E. v. D.J., 2011 BCSC 671 and Buell v. Unger, 2011 BCSC 35; Davey Estate v. Gruyaert, 2005 CarswellBC 3456 at 13 and 35.
[49] In Mother 1, Myers J. concluded his analysis of the law with the following learned comment:
[143] Having canvassed the law relating to the nature of a marriage-like relationship, I will digress to point out the problematic nature of the concept. It may be apparent from the above that determining whether a marriage-like relationship exists sometimes seems like sand running through one's fingers. Simply put, a marriage-like relationship is akin to a marriage without the formality of a marriage. But as the cases mentioned above have noted, people treat their marriages differently and have different conceptions of what marriage entails.
[50] In short, the determination of whether the parties in this case lived in a marriage-like relationship is a fact-specific inquiry that a trial judge would need to make on a “holistic” basis, having regard to all of the evidence. While the trial judge may consider the various factors listed in the authorities, those factors would not be treated as a checklist and no single factor or category of factors would be treated as being decisive.
E. Is There a Reasonable Claim of a Marriage-Like Relationship?
[51] In this case, many of the Molodowich factors are missing:
a) The parties never lived under the same roof. They never slept together. They were never in the same place at the same time during the relationship. The last time they saw each other in person was in November 2017, before the relationship began.
b) The parties never had consensual sex. They did not hug, kiss or hold hands. With the exception of the alleged sexual assault, they never touched one another physically.
c) The parties expressed care and affection for one another, but they rarely shared personal information or interest in their lives outside of their direct topic of communication. They did not write about their families, their friends, their religious beliefs or their work.
d) They expressed concern and support for one another when the other felt unwell or experienced health issues, but they did not provide any care or assistance during illness or other problems.
e) They did not assist one another with domestic chores.
f) They did not share their relationship with their peers or their community. There is no allegation, for example, that Mr. Dorje told his fellow monks or any of his followers about the relationship. There is no allegation that Ms. Han told her friends or any co-workers. Indeed, there is no allegation that anyone, with the exception of Ms. Han’s mother, knew about the relationship. Although Mr. Dorje gave Ms. Han’s mother a gift, he never met the mother and he never spoke to her.
g) They did not intend to have a child together. The child was conceived as a result of a sexual assault. While Mr. Dorje expressed interest in “meeting” the child, he never followed up. He currently has no relationship with the child. There is no allegation he has sought access or parenting arrangements.
[52] The only Molodowich factor of any real relevance in this case is economic support. Mr. Dorje provided the funds with which Ms. Han purchased a condominium. Mr. Dorje initially wrote that he wanted to buy a property with the money, but, he wrote, “It’s the same thing if you buy [it]”.
[53] Mr. Dorje also provided a significant amount of money for Ms. Han’s postpartum care and the child’s first year of life.
[54] This financial support may have been primarily for the benefit of the child. Even the condominium, Ms. Han wrote, was primarily for the benefit of the child.
[55] However, in my view, a trial judge may attach a broader significance to the financial support from Mr. Dorje than child support alone. A trial judge may find that the money Mr. Dorje provided to Ms. Han at her request was an expression of his commitment to her in circumstances in which he could not commit physically. The money and the gifts may be seen by the trial judge to have been a form of down payment by Mr. Dorje on a promise of continued emotional and financial support for Ms. Han, or, in Mr. Dorje’s own words, “Taking care of her and you are my duty for life” (emphasis added).
[56] On the other hand, I find it difficult to attach any particular significance to the fact that Mr. Dorje agreed to provide funds for Ms. Han to purchase a wedding ring. It appears to me that Ms. Han demanded that Mr. Dorje buy her a wedding ring, not that the ring had any mutual meaning to the parties as a marriage symbol. But it is relevant, in my view, that Mr. Dorje provided $20,000 USD to Ms. Han for something she wanted that was of no benefit to the child.
[57] Further, Ms. Han alleges that the parties intended to live together. At a minimum, a trial judge may find that the discussions about where Ms. Han and the child would live reflected a mutual intention of the parties to see one another and spend time together when they could.
[58] Mr. Dorje argues that an intention to live together at some point in the future is not sufficient to show that an existing relationship was marriage-like. He argues that the question of whether the relationship was marriage-like requires more than just intentions, citing Weber, supra.
[59] In my view, the documentary evidence referred to above provides some objective evidence in this case that the parties progressed beyond mere intentions. As stated, the parties appear to have expressed genuine care and affection for one another. They appear to have discussed marriage, trust, honesty, finances, mutual obligations and acquiring family property. These are not matters one would expect Mr. Dorje to discuss with a friend or a follower, or even with the mother of his child, without a marriage-like element of the relationship.
[60] A trial judge may find on the facts alleged by Ms. Han that the parties loved one another and would have lived together, but were unable to do so because of Mr. Dorje’s religious duties and nomadic lifestyle.
[61] The question I raised in the introduction to these reasons is whether a relationship that began on-line and never moved into the physical world can be marriage-like.
[62] Notably, the definition of a spouse in the Family Law Act does not require that the parties live together, only that they live with another person in a marriage-like relationship.
[63] In Connor Estate, 2017 BCSC 978, Mr. Justice Kent found that a couple that maintained two entirely separate households and never lived under the same roof formed a marriage-like relationship. (Connor Estate was decided under the intestacy provisions of the Wills, Estates and Succession Act, S.B.C. 2009, c. 13 ("WESA"), but courts have relied on cases decided under WESA and the FLA interchangeably for their definitions of a spouse.) Mr. Justice Kent found:
[50] The evidence is overwhelming and I find as a fact that Mr. Chambers and Ms. Connor loved and cared deeply about each other, and that they had a loving and intimate relationship for over 20 years that was far more than mere friendship or even so-called "friendship with benefits". I accept Mr. Chambers' evidence that he would have liked to share a home with Ms. Connor after the separation from his wife, but was unable to do so because of Ms. Connor's hoarding illness. The evidence amply supports, and I find as a fact, that Mr. Chambers and Ms. Connor loved each other, were faithful to each other, communicated with each other almost every day when they were not together, considered themselves to be (and presented themselves to be) "husband and wife" and were accepted by all who knew them as a couple.
[64] Connor Estate may be distinguishable from this case because Mr. Chambers and Ms. Connor were physically intimate for over 20 years, and presented themselves to the world as a married couple.
[65] Other decisions in which a marriage-like relationship has been found to exist despite the parties not living together have involved circumstances in which the couple lived under the same roof at previous points in the relationship, and the issue was whether they continued to be spouses after they took up separate residences: in Thompson v. Floyd, 2001 BCCA 78, the parties had lived together for a period of at least 11 years; in Roach v. Dutra, 2010 BCCA 264, the parties had lived together for approximately three years.
[66] However, as Mr. Justice Kent noted in Connor Estate:
[48] … [W]hile much guidance might be found in this case law, the simple fact is that no two cases are identical (and indeed they usually vary widely) and it is the assessment of evidence as a whole in this particular case which matters.
[67] Mr. Justice Kent concluded:
[53] Like human beings themselves, marriage-like relationships can come in many and various shapes. In this particular case, I have no doubt that such a relationship existed …
[68] As stated, Ms. Han’s claim is novel. It may even be weak. Almost all of the traditional factors are missing. The fact that Ms. Han and Mr. Dorje never lived under the same roof, never shared a bed and never even spent time together in person will militate against a finding they lived with one another in a marriage-like relationship. However, the traditional factors are not a mandatory check-list that confines the “elastic” concept of a marriage-like relationship. And if the COVID pandemic has taught us nothing else, it is that real relationships can form, blossom and end in virtual worlds.
[69] In my view, the merits of Ms. Han’s claim should be decided on the evidence. Subject to an overriding prejudice to Mr. Dorje, she should have leave to amend the notice of family claim. However, she should also provide meaningful particulars of the alleged marriage-like relationship.
F. Delay / Prejudice
[70] Ms. Han filed her notice of family claim on July 17, 2019. She brought this application to amend approximately one year and nine months after she filed the pleading, just over two months before the original trial date.
[71] Ms. Han’s delay was made all that more remarkable by her change in position from January 19, 2021, when she confirmed, through counsel, that she was not seeking spousal support in this case.
[72] Ms. Han gave notice of her intention to proceed with this application to Mr. Dorje on March 16, 2021. By the time the application was heard, the parties had conducted examinations for discovery without covering the issues that would arise from a claim of spousal support.
[73] Also, in April, Ms. Han produced additional documents, primarily text messages, that may be relevant to her claim of spousal support, but were undecipherable to counsel for Mr. Dorje, who does not read Mandarin.
[74] This application proceeded largely on documents selected and translated by counsel for Ms. Han. I was informed that Mandarin translations of the full materials would take 150 days.
[75] Understandably in the circumstances, Mr. Dorje argued that an amendment two months before trial would be neither just nor convenient. He argued that he would be prejudiced by an adjournment so as to allow Ms. Han to advance a late claim of spousal support.
[76] The circumstances changed on May 6, 2021, when Madam Justice Walkem adjourned the trial to July 2022 and reset it for 25 days. Madam Justice Walkem noted that most of the witnesses live internationally and require translators. She also noted that paternity may be in issue, and Mr. Dorje may amend his pleadings to raise that issue. It seems clear that, altogether apart from the potential spousal support claim, the parties were not ready to proceed to trial on June 7, 2021.
[77] In my view, any remaining prejudice to Mr. Dorje is outweighed by the importance of having all of the issues between the parties decided on their merits.
[78] Ms. Han’s delay and changes of position on spousal support may be a matter to de addressed in a future order of costs; but they are not grounds on which to deny her leave to amend the notice of family claim.
CONCLUSION
[79] Ms. Han is granted leave to amend her notice of family claim in the form attached as Appendix A to the notice of application to include a claim for spousal support.
[80] Within 21 days, or such other deadline as the parties may agree, Ms. Han must provide particulars of the marriage-like relationship alleged in the amended notice of family claim.
[81] Ms. Han is entitled to costs of this application in the cause of the spousal support claim.
“Master Elwood”
trial test meaning 在 朱學恒的阿宅萬事通事務所 Youtube 的評價
Twitch傳送門: https://www.twitch.tv/otakuarmy2
聽黨指揮,永遠跟黨走,黨在我心中,世界第一免疫橋接疫苗是我大台灣第一,只要聽黨話,病毒也會無力化~~~~我編這個超棒的是不是可以加入民進黨?
根據聯合報的報導:【衛福部食藥署前天通過高端新冠肺炎疫苗緊急授權(EUA)申請,准許專案製造,在野黨批評是照劇本演出。行政院長蘇貞昌今天表示,學者專家高比例來通過,政府也都尊重專業,也請食藥署依據專業程序來走,「請國人同胞相信政府,一定以安全有效為唯一原則」】
高端疫苗通過緊急授權(EUA)這件事不說還好,一說我就有氣。美國評斷疫苗通過與否的過程如何?根據nownews的報導:【美國食品藥品監督管理局(FDA)早前在2020年11月訂出緊急使用授權的相關標準,疫苗解盲的審查過程採取線上直播會議,諮詢委員的投票結果也以公開具名的形式進行。】,【FDA強調,這些諮詢委員經過仔細篩選,排除掉任何存在利益衝突的人士,以便公眾、科學界能夠更清楚的了解新冠疫苗。根據FDA官網,目前諮詢委員會有18個成員,1個席次從缺,主席為德州休斯頓大學醫學院博士、傳染病學教授沙利(Hana El Sahly),成員包括臨床研究、兒科、免疫與呼吸疾病、病理學等各領域的醫學專家,以及行業代表「Head of Medical Affairs」副總裁、FDA生物製品評估研究中心負責人、聯邦政府指定科學顧問。】好啦,鏡頭回到台灣,人家是雞腿,我們是甚麼小?
我們有二十一個藏頭不露臉連名字筆畫生辰八字都不知道的專家,在會議內容完全沒有透露,不要說直播,連錄音綠影都沒有的狀況下,這麼重要攸關全國人民生死的會議竟然就這麼通過了,民眾最多只知道票數而已,媽的這些委員以為自己是蝙蝠俠嗎?藏頭藏尾連紀錄都沒有是有甚麼不可見人的地方?你是專家就要勇敢拿出自己的專業跟社會抗衡啊?!
現在在民進黨擔任黨職月領九萬的林飛帆2014年曾經說,【台灣現行的代議政治、民主制度,已經在行政權專擅獨大的情況底下,被摧毀殆盡;我們現行的代議民主,已經被黨紀、被個人的意志鯨吞蠶食,已經無法回應民意了。】幹,機歪,過了七年之後除了林飛帆薪水增加之外,他媽的台灣狀況越來越糟,我們連土製疫苗怎麼過的都沒有權利知道,這是不是很荒謬?
根據聯合報的報導:【食藥署通過高端疫苗「緊急使用授權」(EUA),並提出「在高端疫苗組AZ疫苗組原型株活病毒」中和抗體幾何平均效價比值的95%信賴區間下限為3.4倍,大於標準要求0.67倍。」,數據漂亮,但中研院院士陳培哲卻說,「這是沒有用的數字,不具有任何參考價值,他連看都不想看。」,放眼全球,也只有台灣這樣做,可說是另類的台灣第一。】
然後最近又有媒體如獲至寶的說日本第一三共使用免疫橋接啦,我國食藥署真是未卜先知啦~~~等等,我上網查了一下不是這樣啊!人家都寫了non-inferiority就是沒說到免疫橋接IMMUNO BRIDGING啊!科學是有甚麼說甚麼,這裡面研究法就是沒提到啊!
日經的日文報導中寫的是非劣性實驗
https://www.nikkei.com/article/DGXZQOUC12116012072021000000/
"治験の詳細は厚生労働省と協議中だが、すでに国内で普及するファイザーやモデルナ製と比べて有効性に遜色がないかを明らかにする「非劣性試験」を採用する見通し。従来の医薬品の治験とは異なり、偽の薬を投与する必要がない。国内外の感染拡大に収束のメドが立たないなか、既存ワクチンがありながら偽薬をうつという倫理的な問題が解消され、治験参加者を集めやすいなどのメリットがある。
日經亞洲的英文原文:Japan nears homegrown vaccine with Daiichi Sankyo Phase 3 trials
https://asia.nikkei.com/Spotlight/Coronavirus/Japan-nears-homegrown-vaccine-with-Daiichi-Sankyo-Phase-3-trials
"So Daiichi Sankyo's next trial is expected to test non-inferiority, meaning that the goal is to show the company's new treatment matches or outperforms those made by Pfizer and Moderna -- also mRNA shots -- in terms of efficacy. Details of the study are being ironed out with the health ministry."
我差點忘記阿亮堅持要談的國防安全院的ptt都是中共同路人的報告了!根據聯合報的報導:【在政府採購COVID-19疫苗策略備受質疑之際,財團法人國防安全研究院發布最新研究報告宣稱,在PTT八卦版發現「奇怪的趨勢」,指稱搧動情緒的敘事模式正逐漸占據跟疫情有關的討論,使得八卦版作為疫情交流平台的功能逐漸癱瘓,而研究使用文字雲等方法,辨識出有267個帳號有協同性質操作相關議題,而且帳號都有快速周旋於不同國家的特性。研究後記認為,在群眾找情緒出口之際,可能以輿論的形式試圖為中國大陸科興與國藥在台打開窗口,對台灣政府製造防疫施政的壓力。】
但是根據風傳媒的報導:【國防研究院日前發布報告,指出網路論壇批踢踢實業坊(PTT)八卦板已被煽動情緒占據,並列出其中47個活躍帳號。不過,國民黨台北市議員徐巧芯徹查這47個帳號,發現這些帳號反國民黨、反中國、支持民進黨的比例高達74%。】現在要打倒反黨反革命只需要意見不同就夠了嗎?連罪證都不用喔,郭正亮有想過國防部底下的智庫可以做這種研究嗎?
另外,昨天最熱鬧的新聞竟然跟郭正亮有關,怎麼搞得! 根據蘋果新聞網的報導:【羽球球后戴資穎揭露東京奧運台灣代表團選手搭經濟艙,在國內引發波瀾,而亞洲羽球強國印尼,也注意到了此事,印尼《Tribun news》今天報導,戴資穎出征東奧搭乘經濟艙,讓戴資穎的父親痛批台灣政府。《Tribun news》這篇報導中,主要是在描述戴資穎父親的說法,指戴爸因為女兒搭經濟艙出征東奧感到不滿,認為應該獲得更好的對待,如果政府無法安排,應該提前通知,讓選手自己安排行程,而不是等選手搭機才知道情況。整篇報導並未提到台灣政府後續作法等等。】
因為郭正亮以前就是體委會副主委,也是羽球協會理事長啊!如果今天他不是被流放,今天大家要罵的就是郭正亮了啦!逃過一劫的郭正亮一定很高興啊哈哈哈,不然我們就問他內幕到底是甚麼啦!
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📍直播大綱:
00:00 開播
03:00 選手參加奧運做經濟艙
18:00 2020/3潘文忠曾保證選手可搭商務艙
39:00 高端過了EUA
01:14:00 談談待用餐
01:25:00 分析國防安全院
trial test meaning 在 朱學恒的阿宅萬事通事務所 Youtube 的評價
馬的郭正亮今天又罵我笨蛋,我說緊急授權不是應該要緊急狀況存在嗎,可是行政院發言人羅秉成說不缺疫苗啊,既然不缺哪裡有緊急狀況需要授權?
為什麼硬要這個時候硬要通過
我跟你講阿宅你這個就不懂了
我又不懂了糟糕
我跟你講
因為當初衛福部對高端做了採購合約
他有一個但書 對
EUA通過之後才能啟動
就是說之前
你的資金不能用
所以我跟你講那個合約
就是這個合約要啟動
你EUA要通過
那是高端急啊關我屁事
所以我說為什麼要這個時候過嘛
裡面有人在配合他
因為他只要過了
那這個合約就可以到銀行貸款
直接把錢領出來
因為這是國家的合同
那他錢領出來要幹嘛去買乖乖嗎
因為他沒錢了
他當然沒錢他本來股本就不夠
然後第二個當然也包括股價一定漲停
我跟你講今天台康台耀國光高端全部漲停
然後聯亞漲29%
所以我跟你講就是基本上
你要從金融面去理解這件事
就是他怎麼那麼急呀
那第一個就是有人要退場
資金從股市退場
那第二個就是這個公司真的沒錢了
那沒錢了 不是看起來
你給他過了萬一他倒了怎麼辦
不會啦
881乘以500萬是40億 怎麼倒
不是啊
但是他如果真的認真要做三期
他如果認真要做三期錢不夠
真正的挑戰是在哪裡
比如說我們這一波AZ打完大概八月中
那平均現在AZ一天大概打到
十六萬到二十幾萬之間
那你如果高端啟用那一天
那結果打得人突然低於五萬呢
那就當然跑啊廢話 要我我也跑啊
阿宅我跟你講
那個時候才是見真章的時刻
就是表示人民的信任到哪裡嘛對不對
就沒有信任啊
那因為它的瑕疵太多嘛
比如說我隨便舉兩個例子
第一個就是
你明明二期完全解盲是十月二十八號
是 因為要過兩百九十天 我如果沒記錯
就將近六個月
你完全解盲還沒完
那表示副作用還有實際的療效
你都不確知
長期觀察沒看到
結果你就急著在七月二十號就急著讓他過
那是什麼意思啊
而且他通過之後
就可以立即開始製造
他EUA是緊急授權可以開始製造
我跟你講今天柯P講一句話是蠻對的
他說可以允許製造
不等於可以允許接種
對對對不一樣
我覺得柯P講這句話真的是對
那為什麼我要讓你試
我為什麼要當白老鼠
因為他後面規定有個很鳥
我跟你講第一個
我要按部就班罵因為這東西實在太多了
我們有二十一個委員
藏頭不露臉名字比劃生辰八字都不知道
他什麼領域專業你也不知道
他姓什麼你也不知道
他長什麼樣你不知道
他在會場講了什麼話你也不知道
通通都不知道的狀況之下 過了
就怕被噹嘛
你如果有專業你怕被噹個屁
阿宅我再講另外一點
國民黨不是開了一個記者會
公佈了食藥署裡面流出來一些文件
那就講到高端的 本來在六月
有三個時間點的製造成品
那有百分之八十二不合格嘛對不對
這個居然跟緊急授權也沒有關係
因為緊急授權只看他的臨床數據
他的中和抗體效價是不是高於AZ
他的標準就是這樣
那至於我製成的品質優不優良
他不管 你知不知道
他只看數字
這個完全是一個很北爛的東西
全世界哪有這種事
你讓他緊急授權是指
他的中和抗體效價夠了嘛 對不對
可是你怎麼可以允許
這個製作的良率這麼低的公司
然後就放心讓他來製造疫苗來讓我們打
而且你不是說
我已經不是良率的問題
是你今天看到的所有數據
是沒辦法證明他真的有抵抗力的
它的T細胞反應到底怎麼樣
我跟你講沒有錯因為中和抗體大概跟B比較連繫
那T細胞怎麼作用不知道
就是因為會產生保護作用
有B細胞跟T細胞
那T細胞通常都是要體內要觀察
它的實際作用才會知道
就是有看過工作細胞的都知道
T細胞是對抗病毒的時候主要作戰能力
也就是在台灣幼稚園到小學生都看得懂
所以為什麼要做三期就這原因
因為要打到人體裡面要做觀察
而且量要夠大 是
要做三、四萬人
那他現在的問題就在這
所以今天路透社發了一個新聞講的很坦白
他說他的臨床實驗沒做完
然後他用的詞是efficacy data
not available
就efficacy就是效力效能效價
連這個最重要的數字都沒有
他就直接這樣寫
然後說可是台灣的衛福部說這樣
他的文章這樣寫
我這樣講因為這個東西真的很誇張
我們再告訴大家
聯亞跟高端是二階中期解盲
但並沒有二階臨床完成
二階臨床還沒有完成
你就申請EUA還過了
陳時中真的很荒謬
還拿去跟全世界其他比
世界上其他的Moderna Pfizer
Johnson & Johnson然後AZ阿斯特捷利康
都是在三期期中報告已經解盲才申請EUA
他們天差地遠好嗎
而且我還是要講美國這個
我一定要唸一下美國的FDA
都會說他的諮詢委員是經過仔細篩選
有排除掉任何存在利益衝突的人士
以便公眾科學界能夠更了解的
更清楚了解新冠疫苗
FDA官網是把這十八個成員
全部列出來有一個席次從缺
他列出來這些人的背景是
德州休士頓大學醫學院博士
傳染病學教授Hana El Sahly
其他成員有臨床研究、兒科專業
免疫與呼吸疾病病理學
還有行業代表Head of Medical Affairs副總裁
還有FDA的生物製品評估研究中心負責人
聯邦政府指定科學顧問
我講到這裡我就問
請問那二十一個人開會的人是誰
阿亮你知道嗎
不知道
我們就這樣講
而且到底是誰投反對票也不知道
連會議紀錄都沒有連錄音錄影都沒有
阿宅我跟你講一點更離譜的
你記不記得昨天食藥署的吳秀梅
她本來怎麼講
她說十八個人只有一票反對
有一票說要補件對不對
那其他都是同意
那今天改口今天說什麼你知道嗎
今天說十五個人是有條件同意
結果我去查什麼叫有條件 兩個條件
第一個每月都要交安全監測報告
第二個
第二個是一年之後要交出保護效益報告書
可是等等等等等等等
我光聽到這裡我就覺得不太爽
你就快昏倒了
你的保護效益
報告書是奠基於中華民國台灣
這些沒有選擇的國民 來當你的白老鼠
在不情願的狀況下接受注射
我問你一下
假設你就開打了 開打了
假設第一個月第二個月這樣下來
有一堆人打了高端嘛
然後他又確診假設有這種狀況
那他的保護效益就會被質疑
那當然 那你要不要喊停
以AZ的狀況我們都死了那麼多人也不喊停
調查應該是不會停 是嘛
他就要一年之後才要他提保護效益報告
那如果說你明明打一個月打兩個月
然後你明明打了之後還確診
那你不用停下來停打
來檢驗一下你的保護效益嗎
你知道我的意思 我知道
這個問題多核心啊
那我們一定要試完一年
才可以看他的保護效力報告
我們這樣講
這什麼邏輯啊
這個網友講的對
三期的受測者
在所謂的各藥廠的三期臨床裡面是拿錢的
我不但有保險
我還要跟你拿錢
一個人所有成本加一加夯不啷噹大概3萬美金左右
那可能我實際拿到手上也許一萬五
因為還要分給醫生 還要給醫生還有護理師
那現在他在台灣是我中華民國
不只免費 是我政府花錢買的
我們花錢買的東西打自己身上
然後給你做報告然後拿去賣給國外
結果你這樣講好了
高端今天又宣布一個好消息
說我們在巴拉圭找到了一千個人做第三期臨床
這個怎麼叫第三期 笑死人
第三期還有一千人的喔
第三期是三萬到四萬
而且你知道他的內容嗎
他說那一千個也是一樣
一半打高端一半打AZ
這個哪裡是第三期
我跟你講這個狀況就完全的
把台灣的狀況
我不知道他在那邊花了多少錢
你把台灣這種不合理的狀況
搬到國外去的時候
我最後還是要講一件事情
你知道那些人
那十五個人說都要交報告的那些人
我只問一件事情
請問阿亮
如果國會要調查這二十一個人是誰
衛福部可不可以
食藥署可不可以保密為由不公開
今天阿中不是講了嗎
說他要提供去識別化的那個審議的過程
我跟你講我就問一件事情
你說我們網友這個仔細想一想
你是中華民國國民
國家要決定有一樣東西
可不可以打到你身上
結果他決定的過程
是叫二十一個沒有臉不知道名字
連他聲音是什麼都不知道
你也不知道他有沒有利益糾葛
而且阿宅我嚴重懷疑這二十一個
可能都打了AZ或莫德納
對啊 不然這二十一個人要不要全打高端
他也不可能
那結果我們在一個不公開不透明的黑箱裡面
決定了中華民國的國民要花多少錢
買這個五百萬劑的疫苗
然後打到我們身上
那你看這個東西到底對不對
我就問阿亮一件事情
你政治學博士
請問什麼時候憲法高度的監督
立法監督行政權力怎麼會低於民法
沒這回事
我們所有的機密預算
都必須在立法院開機密會議
來審查 那對不起疫苗採購不是機密採購
這個是主計處的定義
對主計處已經講了
所以根本就是胡說八道
而且還沒完
他連著二十一個人資料公佈都要去識別化
我就問一件事情
這二十一個人如果是專家
為什麼不敢堂堂正正的面對大家
你今天做了一個決定
然後你說不好意思
我不能露臉我不方便
然後陳時中還說
我怕他們不能暢所欲言
這是國家的政策你說不能暢所欲言
你以為是在酒店叫小姐
你不能暢所欲言不好意思
而且如果是獨步全球的台灣創新
你不是應該要很驕傲嗎
對啊你講出來啊
你到時候告訴全世界
中華民國台灣的高端疫苗用的是
immuno-bridging就是免疫橋接
就是我就是我李秉穎弄的
我叫全世界給我一個諾貝爾獎
就不敢啊
你講到這四個字才令人火大
他說日本也在搞免疫橋接
那到底是怎麼樣
今天風傳媒登了一篇文章
他說日本人家也做非劣性的比較
非劣性比較不等於免疫橋接
他等於是設定一個疫苗來做比較
比如說高端比AZ
人家日本人就很老實
比如說第一三共製藥
因為他是要做mRNA
那他就老老實實的去對比
輝瑞就BNT或者是莫德納
那請問你高端不是做次蛋白疫苗嗎
你為什麼不去對比Novavax呢
你應該要比同級疫苗
你做的是腺病毒就比AZ
為什麼去對比AZ這種腺病毒疫苗呢
我們還是要講
但是之前不是有側翼講說
沒有啊他們做的是類似
我們的免疫橋接的非劣性實驗
我先這樣講
non-inferiority原來都是
大部分是在藥學裡面
藥學裡面的概念就是
舊藥可能有一些副作用或是比較貴
那我今天做了一個新藥
我必須要證明我的新藥
並不比它inferior
就是並沒有比它劣等
也就是我證明我的效能在它以上
那我就有必要做這個新藥
病患就有可以考慮買我的藥
我也許比較便宜也許比較沒有副作用
所以non-inferiority是要經過臨床實驗
不是單純數據在比
你也許中間會有拿抗體或是數據在比
但是你要做non-inferiority
你可以去看藥學的研究報告
都要做臨床
我問過陳秀熙教授
這個如果要做的準
高端要比AZ他說要做十三萬
要做這麼多
樣本要做到十三萬
根本不可能
我們姑且不要講十三萬你做不到
那你為什麼選AZ呢
你是選那個比較好吃的 最差的
因為這個邏輯我再幫阿亮解釋一下
我跟你講我們的網友在我們的教育之下
大概已經變成全世界
國民對疫苗的常識平均了解率已經最高了
AZ目前來講在第一劑第二劑的注射來講
相對它的efficacy是在所有疫苗裡面比較低的
所以你今天Novavax可以超過九成
次蛋白Novavax系列可以超過九成的時候
你高端也做次蛋白 為什麼你的
我們就算高端做的是non-inferiority
就是不比它藥劣的非劣性實驗的時候
為什麼不挑Novavax
你為什麼不挑比較高的你要挑一個AZ
那AZ我們還是要講
各位我對AZ都沒有特別的意見
但它就是一個比較早期的
人類對抗新冠病毒最早的一個武器
最早的武器一定不夠完美
可是現在有個狀況是你拿這個東西來比
而且我們要特別講
我再唸一遍
Daiichi Sankyo's next trial is
expected to test non-inferiority
meaning that the goal is to show
the company's new treatment matches or
outperforms those made by Pfizer and Moderna
also mRNA shots
in terms of efficacy
Details of the study are being ironed
out with the health ministry
就是他還在跟厚生勞動省在討論要怎麼做
但是他們講的很明白
我今天做mRNA我的efficacy就一定是跟mRNA比